UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011801 |
|---|---|
| Receipt number | R000013731 |
| Scientific Title | Is Goreisan effective for preventing postoperative nausea and vomiting?-The randomized controlled trial- |
| Date of disclosure of the study information | 2013/11/30 |
| Last modified on | 2018/09/23 03:04:57 |
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Basic information
Public title
Is Goreisan effective for preventing postoperative nausea and vomiting?-The randomized controlled trial-
Acronym
Is Goreisan effective for preventing postoperative nausea and vomiting?
Scientific Title
Is Goreisan effective for preventing postoperative nausea and vomiting?-The randomized controlled trial-
Scientific Title:Acronym
Is Goreisan effective for preventing postoperative nausea and vomiting?
Region
| Japan |
Condition
Condition
Postoperative Nausea and Vomiting
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Goreisan for postoperative nausea and vomiting with gynecological patients after general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The severity of postoperative nausea and vomiting evaluated by objective scaling number.
The total amount of antiemetic drug dosage used for postoperative nausea and vomiting.
Key secondary outcomes
The severity of postoperative pain evaluated by objective scaling number.
The amount of analgesic drug dosage needed to control patients pain.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food |
Interventions/Control_1
Before the surgical operation is completed, we administer Goreisan through a gastric tube.
Interventions/Control_2
Before the surgical operation is completed, we administer normal saline through a gastric tube.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Gynecological elective surgery patients with general anesthesia
Key exclusion criteria
Severe preoperative complications
Severe postoperative complications
History of the Chinese herb usage
History of the chemotherapy for malignnant deseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ozaki |
Organization
Tokyo Women's Medical University
Division name
Anesthesiology
Zip code
Address
Tokyo, Japan 162-8666
TEL
03-3353-8111
mozaki@anes.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kume |
Organization
Tokyo Women's Medical University
Division name
Anesthesiology
Zip code
Address
Tokyo, Japan 162-8666
TEL
03-3353-8111
Homepage URL
kkume@anes.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京女子医科大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 09 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 18 | Day |
Last modified on
| 2018 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013731
